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RegisterA Nightmare on Elm Street [Study Performance]
posted by Helmut 
– Vienna, Austria, 2013-09-13 18:00 (4671 d 04:20 ago) – Posting: # 11493
Views: 12,142
Hi John,
Again: If you ask Phoenix/WinNonlin for partial AUCs they will be calculated up to/from the requested truncation time point – irrespective of time deviations (like in the plot above). I don’t think that you need an amendment.
Gut feeling. I prefer a 15 min deviation over 45. I’m asking myself how they got two samples at the same time point. Two nurses sticking needles in the left and right arms of the subject competing on who finishes first?
Due to analytical variability the values are expected to be different.
Yes and no. Although the average should be more close to the “true value” you might open a can of worms. Some nitpicking assessor might tell you this value carries undue weight (since all other values are single determinations). Duno.
❝ Exactly... Software wise I think they use both WinNonlin and SAS. I think they can do the interpolation by doing a protocol amendment? I have seen this before and FDA accepted it (not for partial AUC but for other things).
❝ A lot of companies do this because they don't know whether their Kel elimination coding in SAS is "safe" so they need something that is officially validated.
Again: If you ask Phoenix/WinNonlin for partial AUCs they will be calculated up to/from the requested truncation time point – irrespective of time deviations (like in the plot above). I don’t think that you need an amendment.
❝ ❝ The latter (OK, the second one at 4:15). Set the first one to “missing”, “not reportable“, or “oops”.
❝
❝ Why the latter and not the first?
Gut feeling. I prefer a 15 min deviation over 45. I’m asking myself how they got two samples at the same time point. Two nurses sticking needles in the left and right arms of the subject competing on who finishes first?
❝ If they have both samples and the numbers are different?
Due to analytical variability the values are expected to be different.
❝ I think they should take the average?
Yes and no. Although the average should be more close to the “true value” you might open a can of worms. Some nitpicking assessor might tell you this value carries undue weight (since all other values are single determinations). Duno.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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Complete thread:
- Boneheads! jag009 2013-09-09 21:12 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WTF ? Ohlbe 2013-09-09 21:26
- Snafued! Helmut 2013-09-09 21:55
- Snafued! WTF! &%$@! jag009 2013-09-10 16:11
- pAUCs Helmut 2013-09-11 21:01
- pAUCs - the SEQUEL jag009 2013-09-12 20:48
- A Nightmare on Elm Street Helmut 2013-09-13 00:55
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm StreetHelmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 19:57
- A Nightmare on Elm StreetHelmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm Street Helmut 2013-09-13 00:55
- pAUCs - the SEQUEL jag009 2013-09-12 20:48
- pAUCs Helmut 2013-09-11 21:01
- Snafued! WTF! &%$@! jag009 2013-09-10 16:11
- WTF ? jag009 2013-09-10 16:13
- Snafued! Helmut 2013-09-09 21:55
- WTF ? Ohlbe 2013-09-09 21:26
Ing. Helmut Schütz